510(k) K061404

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE by Fci Ophthalmics, Inc. — Product Code OKS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 7, 2006
Date Received: May 19, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lacrimal Stents And Intubation Sets
Device Class: Class U
Regulation Number
Review Panel: OP
Submission Type

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Other clearances by Fci Ophthalmics, Inc.

K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (August 22, 2003)
K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
K991238 — FCI CRAWFORD PROBE INTUBATION SETS (July 8, 1999)
K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (December 20, 1996)

Other clearances for product code OKS

K201892 — Ritleng®+ and Ritleng®+ PVP (March 11, 2021)
K201606 — LacriJet® (December 18, 2020)
K170247 — Lacriflow CL (April 18, 2017)
K161373 — Nunchaku (November 3, 2016)
K160710 — Oasis Lacrimal Intubation Set (May 13, 2016)
K142914 — DacryoCATH (January 12, 2015)
K140290 — STOPLOSS JONES TUBE (December 2, 2014)
K130375 — SELF-RETAINING BICANALICULUS INTUBATON SET II (December 4, 2013)
K123831 — OPHTACATH KIT (July 29, 2013)
K120886 — LACRIFAST (December 17, 2012)